Analytical Method Validation Services

At Pragya Dossier-DMF Services, we specialize in providing comprehensive Analytical Method Validation services aligned with the stringent standards set by the International Council for Harmonisation (ICH) guidelines. Our services are tailored to ensure that your analytical methods are reliable, reproducible, and suitable for their intended purpose.

Key Offerings:

• Method Development & Optimization: We work closely with your team to develop and optimize analytical methods that are both robust and efficient, ensuring they meet the necessary regulatory requirements.

• Validation Protocol Design: Our experts design detailed validation protocols covering all critical aspects such as accuracy, precision, specificity, linearity, range, and robustness, in compliance with ICH guidelines.

• Validation Execution: We execute the validation process meticulously, documenting every step to ensure compliance with regulatory standards. This includes method verification, revalidation, and transfer validation as required.

• Comprehensive Reporting: Upon completion, we provide thorough documentation, including validation reports that meet the highest standards of regulatory submission, ensuring a smooth approval process.

• Regulatory Compliance Support: Our team stays up-to-date with the latest ICH guidelines and global regulatory requirements, ensuring that your validation processes are always in line with current standards.

Partner with Pragya Dossier-DMF Services for your Analytical Method Validation needs, and gain the confidence that your methods are fully validated, compliant, and ready for global regulatory scrutiny.

PDDS provides Analytical Method Validation of API & Formulation Product . Post AMV sale, We provide free support till product registration.

Format and Content : As per ICH / ASEAN / WHO / other country specific guideline
Products:- Pharma Formulation, Bulk (API) & Veterinary

AMV includes: Protocol, report with chromatograms We do AMV Assay, RS, Dissolution & Solvent

AMV Parameters
- Accuracy and Precision
- Specificity and Repeatability
- Intermediate Precision
- Detection Limit
- Quantitation Limit
- Linearity and Range